Experience Areas
Our experience areas include but not limited to -
Clinical Operations
- Clinical Operations on various therapuetic areas like Analgesia, Anti-infectives, Cardiology, CNS, Dermatology, Endocrinology, Haematology, Infectious Diseases, Gastroenterology, Oncology, Ophthalmology, Psychiatry, Respiratory & Allergy, Rheumatology and medical device trials.
- Protocol Development
- Clinical Trial and Site Management
- Clinical Trial Monitoring
- Patient Recruitment
- Quality Assurance
- Regulatory Submissions
Clinical Data Management
- Creation and maintenance of Standard Operating Procedures
- Protocol review and providing inputs to the DM section of the protocol
- Creation and maintenance of DM documents (Data management plan, Edit check specifications, Data entry guidelines, Self evident corrections etc)
- CRF designing
- Database design and Edit check programming
- Data entry and validation, discrepancy management (Paper/EDC)
- Medical Coding - Medical term coding MedDRA,WHODD
- Serious Adverse event reconciliation
- Quality control audits
Biostatistics
- Statistical input to study design and Protocol
- Sample size calculation
- Table, graphs, Listings, Figures
- SAP Designing
- Statistical report writing
Medical Writing
